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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K251727
Device Name GLAM LED Facial Mask (TB-2386F)
Applicant
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
29/F, Block B, Tiley Central Business Plz., Haide 3rd Rd.
Nanshan District
Shenzhen,  CN
Applicant Contact Shidong Qin
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, Huafa Center, 889 Pinglu Rd.
Jing'An District, Shanghai
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/05/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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